Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).

A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Assess the Efficacy and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device for Hemodynamic Support in Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).

The objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd. in providing hemodynamic support for high-risk PCI patients. The main questions it aims to answer are:

During the treatment of high-risk PCI, will the application of the OmniHeart 4.0 percutaneous ventricular assist device achieve hemodynamic support that is not inferior to that of ECMO? What medical problems will occur during or after the treatment for participants who receive the OmniHeart 4.0 percutaneous ventricular assist device during high-risk PCI treatment? The researchers will compare the OmniHeart 4.0 percutaneous ventricular assist device with ECMO (a mechanical circulatory support device) using ECMO as the control group to compare the efficacy differences between the two and thereby evaluate the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device in high-risk PCI treatment.

Participants will:

Be randomly assigned in a 1:1 ratio according to need during high-risk PCI treatment to either the experimental group or the control group. The experimental group will receive the OmniHeart 4.0 percutaneous ventricular assist device for assistance, while the control group will receive the veno-arterial extracorporeal membrane oxygenation (VA-ECMO) device for assistance.

Check-ups and follow-ups will be conducted during the device usage period, at the time of weaning from the device, before discharge, 30 days after surgery, and 90 days after surgery.

The effectiveness endpoint will be evaluated by recording indicators such as the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) free of death within 30 days after surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: High-risk PCI
• Intervention / Treatment: Device: OmniHeart 4.0 Percutaneous Ventricular Assist Device; Device: ECMO

Detailed Description

This clinical trial adopts a prospective, multicenter, randomized controlled, non-inferiority design, with a planned enrollment of 254 subjects. It comprehensively evaluates the safety and effectiveness of the investigational device in human subjects, so as to provide sufficient evidence for the marketing approval and registration of the product in China. The rationale for the trial design is specified as follows:

Prospective design: A prospective study can establish clear causal relationships, with unified diagnostic, testing and evaluation criteria for collected data, thus enabling controllable data processing.

Multicenter design: A multicenter trial can accrue a larger number of cases within the same time frame, thereby shortening the duration of the clinical trial; since a multicenter trial is conducted by multiple clinical investigators across different regions and trial sites, its conclusions generally have broad representativeness.

Randomized controlled trial：

1) Randomization: In this trial, random grouping was conducted using a central randomization system. The Interactive Web Response System (IWRS) automatically assigned groups according to the sequence of enrollment, thereby reducing the bias in the trial caused by sampling errors. A random table was generated by statisticians or designated personnel. The random table was generated by the SAS software based on the preset seed number and block number. A stratified block randomization design by center was adopted, with a ratio of 1:1 between the treatment group and the control group. After verifying the inclusion and exclusion criteria, the researchers entered the subject information into the central randomization system. The researchers clicked the "Randomization" button in the IWRS system, and the system would automatically generate the random grouping of the subjects and provide the feedback through the network to the researchers indicating whether the subject was assigned to the treatment group or the control group. After receiving the randomization results, the researchers provided corresponding treatment to the subjects according to the respective groups. Throughout the entire trial process, the researchers would not be able to modify the group to which the subjects were assigned. For any subjects who completed randomization but withdrew from the clinical trial before starting treatment, their random number (the random number assigned to the subject) would be retained (the random number assigned to the subject would not be reused). Additionally, for those subjects who prematurely withdrew from the clinical trial, no substitution would be provided.

Comparison: In the routine clinical treatment, ECMO is of certain representativeness. Therefore, this product was selected as the control device for this clinical trial. Using the ECMO product as the control, the efficacy differences between the experimental group and the control group were compared to evaluate the effectiveness and safety of the experimental product.

Non-inferiority: To evaluate the experimental device when used in high-risk PCI treatment, the rate of avoiding major adverse cardiovascular and cerebrovascular events (MACCE) within 30 days after surgery was non-inferior to that of the control device.

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin, China
    • The Second Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 1. The patient's age is between 18 and 90 years old (inclusive). 2. There is at least one lesion (including primary lesions and restenosis lesions) in the native coronary artery or grafted bypass vessel, and percutaneous coronary intervention (PCI) needs to be performed under hemodynamic support.

3. The patient meets one of the following conditions:

1. The left ventricular ejection fraction (LVEF) is <=35%, and the vessel to be treated with interventional therapy is an unprotected left main coronary artery lesion or a lesion with only a single remaining open vessel.
2. The left ventricular ejection fraction (LVEF) is <=30%, and the vessel to be treated with interventional therapy is a three-vessel coronary artery lesion.

Among them, a three-vessel coronary artery lesion is defined as follows: there is at least one significant stenosis in each of the three main epicardial coronary arteries (the left anterior descending branch and/or its branches, the left circumflex branch and/or its branches, the right coronary artery and/or its branches). A significant stenosis is defined as a luminal stenosis >= 50% (by visual inspection) or complete occlusion, and at least two vessels have a luminal stenosis >= 70%. For left-dominant coronary arteries, the presence of >= 50% stenosis in both the left anterior descending branch and the proximal left circumflex branch is also regarded as a three-vessel coronary artery lesion.

4. The subject or his/her legal guardian is able to understand the purpose of the trial, voluntarily participates in the trial and signs the informed consent form, and is willing to complete the follow-up as required by the trial.

Exclusion Criteria:

• 1. Acute ST-segment elevation myocardial infarction within 24 hours before enrollment.

  2. Cardiac arrest occurred within 24 hours before enrollment and cardiopulmonary resuscitation was required.

  3. Emergency thrombolysis was performed before enrollment. 4. Cardiogenic shock exists, and cardiogenic shock is defined as follows: (1) Cardiac index (CI) < 2.2 L/min/m² and pulmonary capillary wedge pressure (PCWP) > 15 mmHg; (2) Hypotensive state (systolic blood pressure < 90 mmHg for more than 30 minutes, or systolic blood pressure maintained >= 90 mmHg with the support of vasoactive drugs and/or circulatory assist devices), accompanied by end-organ hypoperfusion (urine output < 30 ml/hour and heart rate > 60 beats/minute, or cold and clammy extremities).

  5. Left ventricular mural thrombus exists. 6. After aortic valve replacement (including mechanical valves, biological valves), implantation of mechanical circulatory assist devices or cardiac contractile devices.

  7. Moderate or severe aortic stenosis, moderate or severe aortic insufficiency. 8. Severe peripheral arterial stenosis or occlusion lesions that interfere with the implantation of the test device or the control device.

  9. Aortic lesions (including aortic aneurysms, aortic dissections, extreme tortuosity or calcification) that interfere with the operation.

  10. Chronic renal insufficiency (serum creatinine >= 4 mg/dl), or dialysis treatment is required.

  11. Liver insufficiency (liver transaminase and bilirubin levels are more than 3 times the upper limit of the normal range).

  12. Uncorrected abnormal coagulation function (platelet count <= 75,000/mm³ or INR >= 2.0 or fibrinogen <= 1.5 g/L).

  13. A history of stroke or transient ischemic attack (TIA) within 1 month before enrollment.

  14. Allergic or intolerant to iodine contrast agents, heparin, aspirin, ADP receptor inhibitors, and with a history of heparin-induced thrombocytopenia (HIT) in the past.

  15. Infectious endocarditis exists or is suspected to exist, or there is a systemic active infection.

  16. Currently participating in other drug/device clinical trials and the primary endpoint has not been reached.

  17. Pregnant or lactating women, those with a fertility plan within 1 year or those who are unwilling to take effective contraceptive measures.

  18. Other situations judged by the investigator as not suitable for enrollment that are unforeseen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; OmniHeart 4.0 Percutaneous Ventricular Assist Device	Device: OmniHeart 4.0 Percutaneous Ventricular Assist Device; The experimental group was treated with OmniHeart 4.0 Percutaneous Ventricular Assist Device
Active Comparator: Control group; Extracorporeal membrane oxygenation (ECMO)	Device: ECMO; The control group received ECMO treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of freedom from major adverse cardiac and cerebrovascular events (MACCE) at 30 days after procedure.	MACCE includes: all-cause mortality, stroke/TIA, myocardial infarction, and repeat coronary revascularization.	30 days after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of freedom from major adverse cardiac and cerebrovascular events (MACCE) at 90 days after procedure.	MACCE includes: all-cause mortality, stroke/TIA, myocardial infarction, and repeat coronary revascularization.	90 days after procedure
The incidence of freedom from major adverse events (MAE) at 30 and 90 days after procedure	MAE includes: all-cause mortality, stroke/TIA, myocardial infarction (MI), repeat coronary revascularization, cardiac or vascular surgery required, acute kidney injury, cardiopulmonary resuscitation/ventricular arrhythmias requiring cardioversion therapy, moderate/severe aortic valve insufficiency, severe hypotension requiring pressor therapy, and failed angioplasty.	30 days and 90 days after procedure
The change in left ventricular ejection fraction (LVEF) from the baseline at 30 and 90 days after procedure		30 days and 90 days after procedure
The change in New York Heart Association (NYHA) functional classification from the baseline at 30 and 90 days after procedure		30 days and 90 days after procedure
Evaluation of device performance (only for the experimental group)	The performance of the device during use is comprehensively evaluated by researchers. The comprehensive evaluation mainly includes: performance of the control unit and performance of the percutaneous implantable catheter pump and infusion components. Control unit performance evaluation: clarity of interface, operational stability, timeliness of alarms, and ease of operation (for professional personnel only). Percutaneous implantable catheter pump and infusion component performance evaluation: pushability of the catheter pump, vulnerability of the catheter pump, stability of pump rate and blood volume delivered (under favorable conditions and stable vital signs), ease of removal of the catheter pump, and usability of the catheter pump and infusion components (for professional personnel only).	Intraprocedure - weaning off

Other Outcome Measures

Outcome Measure	Time Frame
The incidence of all-cause death at 30 and 90 days after procedure.	30 days and 90 days after procedure
The incidence of stroke/transient ischemic attack (TIA) at 30 and 90 days after procedure.	30 days and 90 days after procedure
The incidence of myocardial infarction at 30 and 90 days after procedure.	30 days and 90 days after procedure
The incidence of coronary revascularization at 30 and 90 days after procedure.	30 days and 90 days after procedure
The incidence of the need for cardiac or vascular operation at 30 and 90 days after procedure.	30 days and 90 days after procedure
The incidence of acute kidney injury at 30 and 90 days after procedure.	30 days and 90 days after procedure
The incidence of cardiopulmonary resuscitation/ventricular arrhythmia requiring cardioversion treatment at 30 and 90 days after procedure.	30 days and 90 days after procedure
The incidence of moderate/severe aortic insufficiency at 30 and 90 days after procedure.	30 days and 90 days after procedure
The incidence of severe bleeding at 30 and 90 days after procedure.	30 days and 90 days after procedure
The incidence of severe hemolysis at 30 and 90 days after procedure.	30 days and 90 days after procedure
The incidence of device defects.	30 days and 90 days after procedure

Collaborators and Investigators

• Sponsor: Shanghai Dynaheart Medtech Co., Ltd.
• Collaborators: The Second Hospital of Hebei Medical University; First Affiliated Hospital, Sun Yat-Sen University; Beijing Chao Yang Hospital; Wuhan Asia Heart Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital; The Second Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Xinjiang Medical University; Second Hospital of Jilin University; China-Japan Union Hospital, Jilin University; Zibo Central Hospital; Henan Provincial Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): February 9, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Hemodynamic Support; High-Risk PCI; OmniHeart 4.0
• Other Study ID Numbers: ShanghaiDynaheart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No